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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-01000 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 19-010725 | Other Identifier | Mayo Clinic Institutional Review Board | |
| R33CA240181 | U.S. NIH Grant/Contract | View source |
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Funding issues
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study explores whether DESI-MS can be used to identify cancerous vs. noncancerous tissue during brain tumor surgery.
PRIMARY OBJECTIVES:
I. To explore the translational abilities of desorption electrospray ionization mass spectrometry (DESI-MS) as intraoperative diagnostic tool to:
Ia. Identify cancerous versus noncancerous tissue and estimate the percentage of tumor infiltration in tissue biopsies, by monitoring depletion of N-acetylaspartate (NAA) and aberrations of the phospholipid signature of neurological tissue; Ib. Identify the presence of IDH mutations by monitoring the 2-hydroxyglutarate (2HG) and therefore differentiate between IDH-mutant and wild-type gliomas.
OUTLINE: This is an observational study.
Patients undergo tissue sample collection and DESI-MS during standard of care surgery and have their medical records reviewed on study. Patients also undergo MRI per standard of care on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients undergo tissue sample collection and DESI-MS during standard of care surgery and have their medical records reviewed on study. Patients also undergo MRI per standard of care on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-Interventional Study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological state of the tissue | Will use desorption electrospray ionization mass spectrometry (DESI-MS) to identify cancerous versus noncancerous tissue monitoring depletion of N-acetyl aspartate (NAA) and aberrations of the phospholipid signature (components of the cell membrane) of neurological tissue. | Up to 5 years |
| Percentage of tumor infiltration | Will estimate the percentage of tumor infiltration in tissue biopsies by monitoring depletion of NAA and aberrations of the phospholipid signature of neurological tissue. | Up to 5 years |
| Presence of IDH mutations | Will use DESI-MS to identify the presence of isocitrate dehydrogenase (IDH) mutations by monitoring the 2-hydroxyglutarate (2HG) and therefore differentiate between IDH-mutant and wild-type gliomas. | Up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suspected to have glioma tumors scheduled to undergo tumor resection.
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| Name | Affiliation | Role |
|---|---|---|
| Alfredo Quinones-Hinojosa, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 22, 2024 | Jan 3, 2025 |
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Collected samples will be stored for up to 5 years.
| ICF_000.pdf |
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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